Cleared Traditional

Syngo Carbon Enterprise Access (VA40A)

K240294 · Siemens Healthcare GmbH · Radiology
May 2024
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K240294 is an FDA 510(k) clearance for the Syngo Carbon Enterprise Access (VA40A), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on May 23, 2024, 112 days after receiving the submission on February 1, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K240294 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2024
Decision Date May 23, 2024
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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